Background: Parenteral nutrition (PN) is sometimes required in critically ill children because of contraindication or intolerance to full enteral nutrition. European guidelines recommend favoring multichamber bag PN (MCB PN), when possible, for quality purposes and ease of use. The prescribers may adjust the MCB PN through supplementations to better fulfill patient needs.The objective of this study is to investigate the use and supplementations of MCB PN.Methods: This observational, single-center, retrospective study was conducted in a pediatric intensive care unit (PICU). We collected prescriptions of MCB PNs and their supplementations added directly into PN bags. A descriptive analysis and a comparison of electrolyte supplementations with the manufacturer's recommendations were undertaken.Results: One hundred thirty-five children (median age 39.2 months [7.0-118.8]) were included, 1449 MCB PNs were administered, and 1652 supplementations were carried out in 736 PN bags. Thirty-two percent of supplementations were vitamins, 32.2% were trace elements, and 35.8% were electrolytes. Around 10% of electrolyte supplementations in PN bags were outside the manufacturer's recommendations. These nonconformities primarily concerned phosphate. Conclusion: This study showed the real-world clinical use of MCB PN in the PICU. Proper attention should be paid to septic risks and physicochemical risks to ensure efficient practice and safety of MCB PN use.

BackgroundIn order to monitor the safety of patients in clinical trials, data safety monitoring boards (DSMB) are organised. These DSMB contain independent volunteer experts in the medical field of the research (clinician, pharmacologist, methodologist or statistician). They give their advice about the continuation with or without modification or stopping of the study. They are increasingly questioned by competent authorities during the study authorisation. This is an ambitious challenge to improve the organisation of these DSMB which requires time and work, and relatively few studies have looked at this topic.PurposeOn which types of studies should we concentrate our efforts to implicate experts and optimise these DSMB?Material and methodsThe study design is an observational retrospective study, based on a register of an academic sponsor. It provides data from August 2011 until September 2017 on 89 clinical trials (investigational medical products, medical devices, other than health products) with DSMB. We have analysed the following parameters: type of study, meeting before patient inclusion, meetings during studies and actions taken following the decisions of the DSMB. The implication of experts after a meeting was measured by the decision of experts for all types of studies. We tested the hypothesis that initial meeting before the start of trials may aid a superior involvement of the DSMB members. A Chi-2 test was used in order to compare observed proportions.ResultsSeventy-eight per cent of DSMB recommendations were to modify or stop the trial in Phase I or I/II drugs trials against 36% in the medical devices study, 11% in Phase II and III drugs trials, and 8% in trials other than for health products. The establishment of initial meetings has highlighted the percentages of recommendations by DSMB members of 86% compared to 15% without initial meetings (p<0.0001).ConclusionThe major importance of DSMB decisions were for the precocious drugs phase trials and medical device studies. A DSMB is necessary for these study types, unlike others types. The initial meetings before the start of the study are one of the main parts of this challenge. A national survey is needed in order to validate our results and make recommendations.No conflict of interest